| CTRI Number |
CTRI/2025/06/089063 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of newly developed care protocol for cerebral palsy patients caregivers in enhancing self help. |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of newly developed PACT, structured protocol for the caregivers of cerebral palsy cases as against conventional method to enhance self help and client care in Community setting . |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Indu Alwadkar |
| Designation |
Principal |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Community Health Nursing ,Smt. Radhikabai Meghe Memorial College of Nursing Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
09960278995 |
| Fax |
|
| Email |
indualwadkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Choudhari |
| Designation |
Professor and HOD |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research Department of Community Medicine JNMC, Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
9527538397 |
| Fax |
|
| Email |
sonalic27@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeplata Mendhe |
| Designation |
HOD and Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Community Health Nursing ,Smt. Radhikabai Meghe Memorial College of Nursing Sawangi Meghe
MAHARASHTRA
442001
India |
| Phone |
9527538397 |
| Fax |
|
| Email |
deeplatamendhe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Wardha , India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Indu Alwadkar |
Smt. Radhikabai Meghe Memorial College of Nursing |
Room No. 2, Department of Community Health Nursing, SRMMCON Building, Sawangi Meghe
Wardha
MAHARASHTRA |
09960278995
917122249329
indualwadkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Care givers of patients with Cerebral Palsy will be trained and assessed for self help and patients care |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Practice and Comprehensive Care Therapy |
Practice and Comprehensive Care Therapy will be taught to the care givers of the Cerebral Palsy Patients and will be assessed for improvement in care practices and self help. The duration of intervention will be one week. |
| Comparator Agent |
Routine Care |
Patients of cerebral Palsy and the relatives will get routine care for one week. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
caregivers taking care of a case with cerebral palsy willing to participate in the study
available at the time of data collection
understand Hindi Marathi and English language
provide unpaid care
over 5- 30 years of age of both the genders
|
|
| ExclusionCriteria |
| Details |
caregivers Previously received information through formal training programs on care of cerebral palsy cases
Unwilling to participate in the study
Having chronically ill or having past mental illness |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Developing and Empowerment of self-help groups and improving patient care within the community for patients with cerebral palsy.
Structured care protocols (PACT) will be beneficial for caregivers and patients within the community dealing with cerebral palsy.
|
Assessment will be done at 3 Months and Six Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cerebral
Palsy is one of the most complex of the common permanent disabling conditions .Caregivers
of children with cerebral palsy (CP) have to spend a long time to take care of
their children. Caregivers
plays as essential role on the early identification and observation of growth
pattern of children with cerebral palsy .The study aims to evaluate the efficacy
of PACT (structured care protocols) for the caregivers (self help group)
of cerebral palsy cases as against
conventional method to enhance self help group and patient care in Community . |